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| Name | Class |
|---|---|
| US Department of Veterans Affairs | FED |
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The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic.
Whole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health.
All participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.
The investigators are evaluating a service called peer-delivered Whole Health Coaching to understand how it can help Veterans with PTSD. This project has two main goals: (1) determine how peer-delivered Whole Health Coaching can help Veterans with post-traumatic stress disorder and (2) learning about feasibility of implementing this service in Veterans Health Administration primary care settings. The investigators are also evaluating feasibility of the research methods in this trial to learn how to improve future studies on this topic.
Whole Health Coaching is a service designed to improve health and wellness. It is a variation of integrative health coaching and is being used in Veterans Health Administration medical centers. In Whole Health Coaching, Veterans will work with coaches to develop a personal health mission, develop specific goals and action steps, and then adjust their plan as needed. Coaches provide guidance and support throughout the process. In this project, a peer support specialist working in primary care will be the coach. VA Peer Support Specialists, "peers", are Veterans recovering from a mental health condition trained to help other Veterans improve their health.
All participants will receive peer-delivered Whole Health Coaching. Participants will be randomly assigned a start date for their first session with the Peer Whole Health Coach between 4 and 13 weeks after they start the study. The information provided during this time prior to the first session helps us understand how participants do on their own without the service. The research components include interviews and questionnaires about health and wellness, goals, and experiences with the service. Veterans who participate in the study will complete short questionnaires twice a week for 6 months and have four longer appointments where more questions will be asked. Participants will also be given the opportunity to provide feedback on the service.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peer-delivered Whole Health Coaching | Experimental | Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it will be administered by a peer support specialist. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whole Health Coaching | Behavioral | Veterans Health Administration variation of integrative health coaching. |
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| Measure | Description | Time Frame |
|---|---|---|
| Goal Attainment Scaling (GAS) | Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains. | Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time. |
| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist for DSM-5 (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms. The total sum score ranges from 0-80 with lower scores indicating more positive outcomes. | Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Johnson, PhD | Syracuse VA Medical Center, Syracuse, NY | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VA Medical Center, Syracuse, NY | Syracuse | New York | 13210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Peer-delivered Whole Health Coaching | Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline information is only available for eligible participants (n = 18). Baseline data is missing for one participant who withdrew following randomization prior to completion of the baseline measures resulting in a sample size of n = 17.
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| ID | Title | Description |
|---|---|---|
| BG000 | Peer-delivered Whole Health Coaching | Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer specialist. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Goal Attainment Scaling (GAS) | Goal Attainment Scaling (GAS) is a systematic method used to evaluate participants' individualized goals and progress towards Whole Health goals. Scores range from 0-10 for each domain of whole health measured with higher scores indicating more positive outcomes. Each participant's GAS score reflects the GAS score from the goal domain(s) that the participant identified as primary during the course of the intervention. For participants with multiple goals, GAS scores were average across domains. | Participants were included in this analysis if they initiated peer-delivered Whole Health Coaching within 2 weeks of their designated start date, if they met the baseline stability criterion (at least four data points on the primary outcome, the final two of which had to fall within the range of the previous two data points, for at least 5 of the 9 domains), and if they completed at least three assessments during the intervention phase. | Posted | Least Squares Mean | Standard Error | score on a scale | Participants completed GAS twice weekly throughout the entire 24 week study period and scores were compared over time. |
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24 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peer-delivered Whole Health Coaching | Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-Serious Adverse Event-Unrelated to Study Participation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily M. Johnson, Ph.D., PI | VA Center for Integrated Healthcare | 315-425-4400 | 53487 | Emily.Johnson1@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 28, 2019 | Oct 30, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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All participants will receive peer-delivered Whole Health Coaching but the start date will be randomized between 4 and 13 weeks from initiation of the study.
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| Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains. The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care). Scores range from 0-100 with lower scores indicating more positive outcomes. | Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period. |
| Client Satisfaction Questionnaire | Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service. CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes. | 8 weeks following intervention onset |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Title |
|---|
| Description |
|---|
| OG000 | Peer-delivered Whole Health Coaching | Whole Health Coaching is a Veterans Health Administration variation of integrative health coaching. For this study it was administered by a peer support specialist. |
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| Secondary | PTSD Checklist for DSM-5 (PCL-5) | The PTSD Checklist for DSM-5 (PCL-5) is a measure of participants' PTSD symptoms. The total sum score ranges from 0-80 with lower scores indicating more positive outcomes. | Only participants included in the primary analysis are analyzed here. | Posted | Least Squares Mean | Standard Error | score on a scale | Participants completed the PCL-5 at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period. |
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| Secondary | Inventory of Psychosocial Functioning (IPF) | The Inventory of Psychosocial Functioning (IPF) is a measure of psychosocial functioning across several domains. The total score was used for this project and reflects a composite of multiple subscales (romantic relationships, family, work, friendships and socializing, parenting, education, and self care). Scores range from 0-100 with lower scores indicating more positive outcomes. | Only participants meeting criteria for inclusion in the primary analysis are included here. | Posted | Least Squares Mean | Standard Error | score on a scale | Participants completed the IPF at baseline, pre-treatment, post-treatment, and final follow-up assessments over the course of the 24 week study period. |
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| Secondary | Client Satisfaction Questionnaire | Measure of participants' satisfaction with the peer-delivered Whole Health Coaching service. CSQ-8 scores range from 8-32 with higher values indicating more positive outcomes. | The CSQ-8 was analyzed for all participants with non-missing data at this timepoint. | Posted | Mean | Standard Deviation | score on a scale | 8 weeks following intervention onset |
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| 0 |
| 18 |
| 0 |
| 18 |
| 1 |
| 18 |
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| Follow-up (24 weeks) |
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| Follow-Up (24 weeks) |
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